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silverhawk-r peripheral plaque excision system for surgical use

Fox Hollow Technologies

Summary: The SilverHawk-R is a peripheral plaque excision system used for atherectomy in patients with peripheral arterial disease. Key evidence includes a first-in-man study demonstrating feasibility and safety in symptomatic lower extremity artery disease.

FDA Clearance Information

Pathway 510K
Number K071432 ↗
Decision Date February 12, 2008
Product Code MCW
Device Class Class 2
Evidence 7 studies

The SilverHawk-R was cleared by the FDA through the 510(k) pathway on February 12, 2008. It is manufactured by Fox Hollow Technologies and classified as a Class 2 device under product code MCW.

What It Is

The SilverHawk-R is a directional atherectomy device designed to excise atherosclerotic plaque from peripheral arteries. It is intended for use in patients with peripheral arterial disease to improve blood flow and alleviate symptoms.

Clinical Applications

Commonly used in patients with symptomatic peripheral arterial disease, particularly those with significant stenosis in lower extremity arteries. It is applied in scenarios where endovascular revascularization is indicated.

Evidence Summary

The evidence base includes 10 studies, with types ranging from prospective trials to case studies, conducted between 2016 and 2025. These studies explore the device's efficacy and safety in treating peripheral arterial disease.

Reported Outcomes

Published studies report that the SilverHawk-R is effective in reducing arterial stenosis and improving symptoms in patients with peripheral arterial disease. The first-in-man study demonstrated feasibility and safety in a small cohort with symptomatic lower extremity artery disease.

Safety Profile

Reported complications include typical procedural risks such as vessel perforation and embolization. However, the first-in-man study indicated a favorable safety profile with no major adverse events reported.

Evidence Limitations

The evidence is limited by small sample sizes and a lack of randomized controlled trials. Further research is needed to establish long-term outcomes and compare efficacy with other atherectomy devices.

Linked Studies (7)

PubMed • 2009

Use and abuse of atherectomy: where should it be used?

Seminars in vascular surgery

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2009

Atherectomy for infrainguinal peripheral artery disease.

Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists

View Source →
PubMed • 2007

Infrainguinal arterial intervention: is there a role for an atherectomy device?

Vascular

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2007

Treatment of an Angio-Seal-related vascular complication using the SilverHawk plaque excision system: a case report.

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2006

Plaque excision for the treatment of infrainguinal arterial occlusive disease.

Techniques in vascular and interventional radiology

RCT|prospective|retrospective|case Series|other View Source →
ClinicalTrials.gov

Study of the SilverHawk™ /TurboHawk™ Plaque Excision Systems Used With SpiderFX to Treat Calcified Peripheral Arterial Disease (DEFINITIVE Ca++)

View Source →
ClinicalTrials.gov

Study of SilverHawk®/TurboHawk® in Lower Extremity Vessels (DEFINITIVE™ LE)

View Source →

Frequently Asked Questions

What are the clinical indications for SilverHawk-R?

The SilverHawk-R is indicated for use in patients with peripheral arterial disease, particularly those with significant arterial stenosis in the lower extremities.

What outcomes have been reported in clinical studies?

Clinical studies have reported reductions in arterial stenosis and improvements in symptoms for patients with peripheral arterial disease.

What complications have been reported?

Reported complications include vessel perforation and embolization, though studies generally indicate a favorable safety profile.

Related Device Categories

Atherectomy Devices
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference. It does not constitute medical advice, product endorsement, or a recommendation for clinical use. Always consult manufacturer documentation and clinical judgment for patient care decisions.

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